DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)LIST OF UPDATESUPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE1.January2013Section A, 7.Use of HalalLogoAddition of the following:a) Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2 at a)Generics (non-scheduled poison), excluding parenteraldosage form and veterinary products.b) As last paragraph:Applicant shall submit application for variation type II toNPCB for approval to affix halal logo on product label of aregistered product of which a halal certification has beengranted. A copy of the halal certificate must be submittedas a supporting document.Circular(95)dlm.BPFK/PPP/01/03Jld. 2, 26 December 2012:Penggunaan Logo HalalBagi ProdukFarmaseutikal berdaftarkategori produk bukanracun, OTC2.January2013Section A,1.3.2Classification ofFDI ProductsAddition of the following:Notes:Applicant shall verify on FDI product classification with NPCB inorder to determine whether the product shall be registered bythe Authority or otherwise.Reference: Circular (97)dlm.BPFK/PPP/01/03 Jld. 2Circular(97)dlm.BPFK/PPP/01/03Jld. 2, 27 December 2012:Pengkelasan ProdukFood-Drug InterfaceNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 480
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE3.January2013Section E, 14.Maintenance ofRegistrationAt 14. Maintenance of Registration:Addition of the following paragraph:In order to maintain registration of an imported product, startingon 1 st January 2014, applicant shall comply with GMPrequirement as stated in the directive issued by the Director ofPharmaceutical Services under Regulation 29, CDCR 1984Arahan Bil. 1 Tahun 2012 Syarat Pendaftaran ProdukFarmaseutikal Dari Luar Negara Berkaitan Keperluan AmalanPerkilangan Baik (APB) (Reference: Circulars Bil (25) dlmBPFK/PPP/01/03 Jld 1 and Bil (96)dlm.BPFK/PPP/01/03 Jld. 2).The Authority shall not consider any renewal application thatfails to comply with the stipulated requirement.At 16.2.2 Conditions on Good Manufacturing Practice (GMP):Addition of a hyperlink of Bil (96)dlm.BPFK/PPP/01/03 Jld. 2), 28December 2012: Surat Pekeliling Bagi Direktif Mengenai SyaratPendaftaran Produk Farmaseutikal Dari Luar Negara BerkaitanKeperluan Amalan Perkilangan Baik (APB)Directive Bil (25) dlmBPFK/PPP/01/03 Jld 1, 9February 2012: DirektifMengenai SyaratPendaftaran ProdukFarmaseutikal Dari LuarNegara BerkaitanKeperluan AmalanPerkilangan Baik (APB)andCircular(96)dlm.BPFK/PPP/01/03Jld. 2, 28 December 2012:Surat Pekeliling BagiDirektif Mengenai SyaratPendaftaran ProdukFarmaseutikal Dari LuarNegara BerkaitanKeperluan AmalanPerkilangan Baik (APB)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 481
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Appearance/organoleptic(odor, color
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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